Head and Neck CancerPhase 1NCT01668849
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
A Phase 1 study testing Grape extract and Lortab, Fentanyl patch, mouthwash in people with Head and Neck Cancer and Oral Mucositis, run by University of Louisville at 1 site in United States.
Trial summary
This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Head and Neck Cancer, Oral Mucositis
- What is being tested?
- Grape extract and Lortab, Fentanyl patch, mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2012to 3 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have definitive diagnosis of head and neck cancer.
- Concurrent chemoradiation treatment of the primary tumor must be an option for the newly diagnosed cancer.
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
- Absence of life limiting medical conditions
- Ability to understand and willingness to sign a written informed consent document.
- ECOG performance status 0, 1, or 2 (Karnofsky > 60%).
- Patients must have adequate bone marrow function. ANC > 1000/microL and Platelet count >100,000/microL
- Age >20 years
Who cannot join
- Known familial head and neck cancer syndrome
- Pregnancy
- Known HIV
- Patients receiving immunosuppressive drugs
- Inflammatory bowel disease
- Active second malignancy in the last 5 years
- Patients receiving any other investigational agent(s)
- Patients who have received any prior chemotherapy or radiation therapy to the primary head and neck cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Abrogate Oral Mucositis Induced by Combined Chemotherapy and Radiation in Head and Neck Cancer Patients
This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.
Read the detailed description
The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be evaluated is the effect of grape exosomes on the production of cytokines and immune responses to tumor exosomal antigens, metabolic and molecular markers in these patients.
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Being tested
- Grape extract, Lortab, Fentanyl patch, mouthwash
- Keywords
- Plant exosomes, Grape exosomes, Grape extract, Oral mucositis, Head and Neck Cancer, Immune response
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape extractDietary supplement
Grape extract self-administered by mouth daily for 35 days
Lortab, Fentanyl patch, mouthwashDrug
Also called Lortab 5-10 mg, Fentanyl patch 25 mcgs, Mary's Magic Mouthwash
Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
| Study group | Role | What they receive |
|---|---|---|
| 1 - Grape extract | Experimental | Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy. Receives: Dietary Supplement: Grape extract |
| 2 - Lortab, Fentanyl patch, mouthwash | Active comparator | Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels. Receives: Drug: Lortab, Fentanyl patch, mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain caused by oral mucositis
Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.
Measured: Total followup of six months
Secondary outcomes (2)
Level of immune biomarkers in blood
Levels of immune biomarkers (cytokines, T cells NK Cells CD11cIL12)in the blood at the time of completion of radiation therapy will be compared to baseline levels.
Measured: Within three days of the completion of radiation therapy which will last approximately 30 days.
Level of immune biomarkers in mucosal tissue
Levels of immune biomarkers (CD3, CD8, CD11b, F4/80, BRDU)in scrapings of mucosal tissue at the time of completion of radiation therapy will be compared to baseline levels.
Measured: Within three days of the completion of radiation therapy which will last approximately thirty days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study start2 Aug 2012
- Primary completion25 May 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Rebecca Redman, University of Louisville
- Investigators
- Rebecca Redman, MD, Principal investigator, James Graham Brown Cancer Center, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668849
- Sponsor's protocol ID
- 12.0220
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2012
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu K, Xing F, Wu SY, Watabe K. Extracellular vesicles as emerging targets in cancer: Recent development from bench to bedside. Biochim Biophys Acta Rev Cancer. 2017 Dec;1868(2):538-563. doi: 10.1016/j.bbcan.2017.10.001. Epub 2017 Oct 18.
PubMed 29054476
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Abrogate Oral Mucositis Induced by Combined Chemotherapy and Radiation in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01668849
- Acronym / sponsor ID
- 12.0220
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Keywords
- Plant exosomes, Grape exosomes, Grape extract, Oral mucositis, Head and Neck Cancer, Immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- 2 Aug 2012 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.
Detailed description
The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be evaluated is the effect of grape exosomes on the production of cytokines and immune responses to tumor exosomal antigens, metabolic and molecular markers in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Grape extract | Experimental | Dietary Supplement: Grape extractGrape extract self-administered daily by mouth for 35 days during chemoradiation therapy. |
| 2 - Lortab, Fentanyl patch, mouthwash | Active comparator | Drug: Lortab, Fentanyl patch, mouthwashStandard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have definitive diagnosis of head and neck cancer.
- Concurrent chemoradiation treatment of the primary tumor must be an option for the newly diagnosed cancer.
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
- Absence of life limiting medical conditions
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (8 listed)
- Known familial head and neck cancer syndrome
- Pregnancy
- Known HIV
- Patients receiving immunosuppressive drugs
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape extractGrape extract self-administered by mouth daily for 35 days | Dietary supplement | 1 - Grape extract |
| Lortab, Fentanyl patch, mouthwashAlso: Lortab 5-10 mg, Fentanyl patch 25 mcgs, Mary's Magic MouthwashLortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash | Drug | 2 - Lortab, Fentanyl patch, mouthwash |
Primary outcome
Pain caused by oral mucositis
Time frame: Total followup of six months
Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.
2 secondary outcomes
Level of immune biomarkers in blood
Time frame: Within three days of the completion of radiation therapy which will last approximately 30 days.
Level of immune biomarkers in mucosal tissue
Time frame: Within three days of the completion of radiation therapy which will last approximately thirty days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 29054476Wu K, Xing F, Wu SY, Watabe K. Extracellular vesicles as emerging targets in cancer: Recent development from bench to bedside. Biochim Biophys Acta Rev Cancer. 2017 Dec;1868(2):538-563. doi: 10.1016/j.bbcan.2017.10.001. Epub 2017 Oct 18.
- James Graham Brown Cancer Center, Louisville, KentuckyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Redman, MD principal investigator
James Graham Brown Cancer Center, University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Grape extract and Lortab, Fentanyl patch, mouthwash in people with Head and Neck Cancer and Oral Mucositis, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain caused by oral mucositis (time frame: Total followup of six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.